Women's Health Weekly
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Breast Implants
PMA submitted for next-generation silicone gel-filled breast implants
December 30th, 2004
Inamed Corporation (NASDAQ:IMDC) announced on December 6, 2004, two significant events affecting its Breast Aesthetics franchise: 1) it has submitted a premarket approval application (PMA) with the U.S. Food and Drug Administration (FDA) for its "next generation" Bio- Dimensional Cohesive Gel Matrix (Style 410) breast implants; and 2) it has been notified by the FDA that its supplemental submission for its pending silicone gel-filled breast implants PMA will be reviewed at a tentatively scheduled meeting of the FDA's General and Plastic Surgery Devices Advisory Panel in April 2005. "[This] announcement...
Source: Women's Health Weekly (2004-12-30)
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